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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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LASIK Back to Search Results
Event Type  Other  
Event Description

Typical event problems getting progressively worse -i. E. Severe dry eyes-. Becoming more difficult to drive without sunglasses in daytime and bad glare, halo, etc. At night. Also, have what was diagnosed as a cataract forming on left eye. Surgery was done (b) (6) 1998, at the (b) (6) eye institute by dr (b) (6) and cost (b) (4). I was told i would have to wear a contact lense in left eye at 1. 50 magnification or wear reading glasses. I wore the soft contact lense for almost one year and then changed to reading glasses and currently, cannot find an eyeglass lense that helps correct what is also needed for distance. Date of last eye exam was (b) (6) 2009.

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Brand NameUnknown Brand Name
Type of DeviceLASIK
MDR Report Key1580953
Report NumberMW5014358
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 01/12/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/12/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator OTHER
Is The Reporter A Health Professional? No